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Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism (T4-T3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00531713
First Posted: September 19, 2007
Last Update Posted: September 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Copenhagen University Hospital at Herlev
  Purpose
To compare the effect of T4-T3 combination therapy versus T4 monotherapy in patients with autoimmune hypothyroidism, on stable T4-substitution therapy

Condition Intervention Phase
Quality of Life Depression Drug: Triiodothyronine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism,a Double Blind Randomized Cross-Over Study.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Selv-rating scales: SF-36, SCL -90-R, BDI [ Time Frame: 3 month treating ]

Secondary Outcome Measures:
  • BMI, bioimpedance [ Time Frame: 3 month treament ]

Enrollment: 59
Study Start Date: April 2003
Study Completion Date: March 2007
Arms Assigned Interventions
No Intervention: 1
Usual T4 dose is given
Active Comparator: 2
20 microgram of T3 is given and 50 microgram of T4 is withdrawn
Drug: Triiodothyronine
50 microgram of the usual T4 is withdrawn and the patients is given 20 microgram of T3

Detailed Description:
double blind randomized cross-over study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypothyroidism, S-TSH> 20 at diagnosis,Anti-TPO >300 Normal TSH (0,4-4,0) for 6 months.

Exclusion Criteria:

  • <18 år
  • >75 år
  • pregnant women
  • Thyroid cancer
  • T3 treatment
  • Post-partum thyroiditis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531713


Locations
Denmark
Dept of endocrinology , Herlev Hospital
Herlev, Denmark, dk-3650
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Birte Nygaard Herlev Trials
  More Information

ClinicalTrials.gov Identifier: NCT00531713     History of Changes
Other Study ID Numbers: T4-T3 hypothyreose
KA 02022ms
First Submitted: September 18, 2007
First Posted: September 19, 2007
Last Update Posted: September 19, 2007
Last Verified: September 2007

Keywords provided by Copenhagen University Hospital at Herlev:
hypothyroidism, quality og life, depression

Additional relevant MeSH terms:
Depression
Hypothyroidism
Behavioral Symptoms
Thyroid Diseases
Endocrine System Diseases